Task-specific Epidural Stimulation Study (TSEPI)

Task and Physiological Specific Stimulation for Recovery of Autonomic Function, Voluntary Movement, and Standing Using Epidural Stimulation and Training After Severe Spinal Cord Injury

The investigators propose to understand the role of lumbosacral spinal cord epidural stimulation (scES) in recovery of autonomic nervous system function, voluntary movement, and standing in individuals with severe spinal cord injury (SCI). Thirty-six individuals with severe SCI who have cardiovascular and respiratory dysfunction and who are unable to voluntarily move the legs or stand will receive scES for cardiovascular function, voluntary movement, or standing with and/or without weight-bearing standing. Training will consist of practicing voluntary movements or standing in the presence of specific scES configurations designed for the voluntary movements of the legs and trunk (Vol-scES), or epidural stimulation configurations specific for standing (Stand-scES). Specific configurations epidural stimulation for cardiovascular function (CV-scES) will be provided during sitting and supine and during maneuvers of orthostatic or cardiovascular stress. The ability to move voluntarily, stand, as well as cardiovascular, respiratory, bladder, bowel and sexual function will be assessed in these individuals with chronic severe spinal cord injury. Quality of life and costs of health care also will be assessed.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Epidural Stimulation; Biological: Stand Training

Detailed Description

Experimental Design

The investigators will enroll, implant and complete the interventions in 36 research participants who have sustained a SCI in the proposed experiments. The investigators anticipate they will need to screen 108 potential research participants to enroll 36 individuals who will complete the study. This sample size will provide sufficient replication per study group (n=4) from which variance and effect size estimates for each study hypothesis can be calculated, and hypothesis tests conducted. The investigators will also select individuals to assure that there are a minimum of 25% (n=9) women to adequately represent the percentage in the SCI population. The investigators will study each cohort of patients comprehensively, and each individual will be allocated to the group interventions based on the method of minimization. Research participants will be randomized into group interventions. This novel approach of conducting repeated experiments with comprehensive assessments in a smaller cohort of patients, rather than a more traditional approach of including a large number of patients and focusing on a single outcome, will advance both clinical and scientific knowledge in this highly complex population. The investigators have found success with the smaller cohort approach because they can employ more rigorous, quantitative and sensitive outcomes that not only inform them about the potential clinical efficacy, but also provide further knowledge of the mechanisms of neural control of movement and other physiological mechanisms related to cardiovascular, respiratory, bladder, bowel and sexual function.

Group A:

• Vol-scES during voluntary leg movement training while sitting or lying supine (A1).
• CV-scES during sitting or lying supine (A2).

Group B:

• Vol-scES during voluntary leg movement training + Stand-ES during stand training (B1).
• CV-ES during sitting or lying supine + Stand-ES during stand training (B2).

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan J Harkema, PhD; Phone Number: 502-582-7443; Email: susan.harkema@louisville.edu
• Study Contact Backup: Name: Manpreet A Chopra, BAMS; Phone Number: 502-582-7443; Email: manpreet.chopra@louisville.edu

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Recruiting
      • University of Louisville
      • Contact: Susan Harkema, PhD; Phone Number: 502-582-7443; Email: susan.harkema@louisville.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• At least 18 years of age
• Non-progressive spinal cord injury
• At least 2 years post injury
• Stable medical condition
• Unable to voluntarily move all individual joints of the legs
• Unable to stand independently
• Cardiovascular dysfunction including presence of persistent low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in a 24 hour period
• Urodynamic dysfunction including dyssynergia and/or inability to void voluntarily and/or low voiding capacity
• Respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes

Exclusion Criteria:

• Ventilator dependent
• Untreated painful musculoskeletal dysfunction, fracture or pressure sore
• Untreated psychiatric disorder or ongoing drug abuse
• Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury
• Bladder botox injections less than 12 months prior to implant
• Colostomy bag, urostomy
• Any implanted pump (i.e., baclofen pump, pain pump, etc)
• Ongoing nicotine use
• Pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Voluntary Movement Epidural Stimulation; Participants assigned to this group will receive epidural stimulation specific for voluntary movement.	Device: Epidural Stimulation; Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.
Experimental: Cardiovascular Epidural Stimulation; Participants assigned to this group will receive epidural stimulation specific for cardiovascular function.	Device: Epidural Stimulation; Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.
Experimental: Voluntary Movement ES + Stand Training; Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.	Device: Epidural Stimulation; Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.; Biological: Stand Training; Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.
Experimental: Cardiovascular ES + Stand Training; Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.	Device: Epidural Stimulation; Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.; Biological: Stand Training; Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recovery of autonomic control of cardiovascular function as assessed by cardiovascular assessments	20 months
Recovery of voluntary movement as assessed by functional movement assessments	20 months

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Christopher Reeve Paralysis Foundation
• Investigators: Principal Investigator: Susan J Harkema, PhD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 6, 2017

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; Epidural Stimulation; Task-Specific
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 16.0179 TS EPI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes